Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Impact of grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination
研究概览
简要总结
To learn how radiation treatment may affect your responses to vaccines against pneumonia.
详细描述
Primary Objectives
- Determine the impact of Grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination.
Secondary Objectives
- Determine the impact of chemoradiation on serologic responses to pneumococcal vaccination.
- Determine the impact of radiation modality on serologic responses to pneumococcal vaccination.
- Determine the impact of radiation modality on systemic immunity.
- Determine the incidence of pneumonia among patients treated with a pneumococcal vaccine.
- Determine the impact of radiation modality on pathologic response.
- Determine the impact of radiation modality on intratumoral immunity.
- Determine the relationship between changes in systemic and intratumoral immunity and clinical outcomes (i.e., incidence of pneumonia and pathologic response)
- Determine the impact of tumor histology on serologic responses to pneumococcal vaccination.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with protons.
- •a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with intensity-modulated radiation therapy (IMRT)
- •a. Patients currently receiving, planning to receive, or recently completed definitive proton therapy for unresectable liver cancer.
- •a. Patients currently receiving, planning to receive, or recently completed definitive IMRT for unresectable liver cancer.
- •a. Healthy age- and gender- matched individuals
- •Patients of all genders, races and nationalities will be solicited.
- •Age >18 years
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients with compromised immunologic responses due to an uncontrolled intercurrent immunodeficiency (e.g., Human immunodeficiency virus (HIV), X-linked agammaglobulinemia) or previous or current immune suppressive therapy
- •a. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- •Patients receiving intravenous immunoglobulin (IVIG) during the study or in the three months prior to study enrollment.
- •Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- •Individuals with previous pneumococcal vaccination in the last 5 years.
- •Individuals with severe allergy to any of the vaccine components
研究组 & 干预措施
Group 3
20 Healthy Volunteers.
干预措施: Pneumonia vaccine (Biological)
Group 1
30 participants currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer. This group will be subdivided into Group 1A, which will comprise 15 participants treated with proton therapy, and Group 1B, which will comprise 15 patients treated with intensity modulated radiation therapy (IMRT).
干预措施: Pneumonia vaccine (Biological)
Group 2
30 participants currently receiving, planning to receive, or recently completed chemoradiation for hepatocellular carcinoma. This group will be subdivided into Group 2A, which will comprise 15 participants treated with proton therapy, and Group 2B, which will comprise 15 patients treated with intensity modulated radiation therapy (IMRT).
干预措施: Pneumonia vaccine (Biological)
结局指标
主要结局
Impact of grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination
时间窗: through study completion; an average of 1 year
Serologic responses will be calculated as the average fold change in antibody titer for each of 20 pneumococcal serotypes between baseline (time 0) and the first post-vaccination blood draw.
次要结局
未报告次要终点